ellaOne film tablet 30 mg

What is ellaOne and when is it used?

ellaOne is an emergency contraceptive

ellaOne is an oral emergency contraceptive for all women of childbearing potential. It can be taken to prevent pregnancy after unprotected sex or contraceptive failure, for example:

• if you have had unprotected sex; if your partner's condom broke, slipped or came off, or if you forgot to use a condom;if you did not take your birth control pills as recommended.

You should take ellaOne as soon as possible after intercourse, but no later than 5 days (120 hours) afterwards.

Such medicines are also known as the "morning after pill".

You can take ellaOne at any point in the menstrual cycle.ellaOne contains the active ingredient ulipristal acetate, which changes the effect of the natural hormone progesterone, which is necessary for ovulation. As a result, ellaOne delays ovulation. Emergency contraception is not effective in all cases: about 2 out of 100 women taking ellaOne will still become pregnant.ellaOne is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not lead to the termination of the existing pregnancy.Dispensing is carried out exclusively by the doctor or pharmacist. Before dispensing, it must be clarified in a consultation whether the preparation is suitable for you. If you do not have a menstrual period, a medical check-up is required.

What should you pay attention to?

ellaOne is not effective if you are already pregnant.If your If your period is late, there is a chance you are pregnant. If your period is late or you experience symptoms of pregnancy (heavy breasts, morning sickness), consult a doctor or pharmacist before taking ellaOne. If you have unprotected sex after taking ellaOne, you can still get pregnant.You can get pregnant with unprotected sex at any time during your cycle.ellaOne is not suitable for regular contraception.If you don't use a regular method of birth control, talk to your doctor to choose a method that's right for you.Emergency birth control doesn't provide one Protection against sexually transmitted diseases.Only condoms can protect you against sexually transmitted diseases. ellaOne offers no protection against HIV infection or other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis). Contact your doctor or pharmacist if you have any concerns.

When shouldn't ellaOne be taken?

ellaOne shouldn't be taken if you are hypersensitive to the active substance ulipristal acetate or one of the excipients. If you are pregnant or think you may be pregnant, you must not take ellaOne. You should also not take ellaOne if you have severe liver disease.

When is caution required when taking ellaOne?

Please inform your doctor or pharmacist before you Take ellaOne:

• if you have liver diseasesuffer;if you suffer from severe asthma;if your period is late or you are experiencing symptoms of pregnancy (heavy breasts, morning sickness) as you may already be pregnant (see "Can ellaOne be taken while pregnant or breastfeeding?").

After taking ellaOne, ovulation can return within the same menstrual cycle. Therefore, if you have intercourse again after using ellaOne, you must use a barrier method of contraception (e.g. a condom) because ellaOne will no longer be effective if you have unprotected sex again.If you are currently using hormonal contraceptives ( e.g. a «birth control pill»), you can continue taking it as usual after using ellaOne; However, you should use an additional barrier method of contraception, such as a condom, until your next menstrual period (see below).If you become pregnant despite taking ellaOne, it is important that you consult your doctor or contact your doctor. In this case, the doctor should examine whether an abdominal cavity or ectopic pregnancy is present (see «Can ellaOne be taken during pregnancy or while breastfeeding?»).Emergency contraception with ellaOne cannot always prevent pregnancy from occurring. Therefore, refrain from taking medicines and consuming alcohol and nicotine until you have finally ruled out pregnancy.ellaOne must not be used together with emergency contraceptives that contain levonorgestrel. Taking it together can reduce the effectiveness of ellaOne.

Taking ellaOne with other medicines

It is essential that you inform your doctor or pharmacist if You are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines. Some medicines can reduce the effectiveness of ellaOne. You must tell your doctor or pharmacist if you have taken any of the following medicines in the last 4 weeks, as there may be interactions with ellaOne and your doctor has prescribed a different type (non-hormonal) of could prescribe emergency contraception, i.e. a copper IUD:

• Drugs to treat epilepsy (e.g. barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone);Drugs to treat certain bacterial infections such as tuberculosis (e.g. rifabutin, rifampicin);Drugs to treat HIV infection (protease inhibitors e.g. ritonavir, efavirenz, nevirapine);Drugs to treat Treatment of high blood pressure in the pulmonary circulation (e.g. bosentan)Medicines to treat narcolepsy, a special type of excessive sleepiness (e.g. modafinil)Herbal medicines containing St. John's wort (Hypericum perforatum) for Treatment of depression or anxiety.

Inform your doctor or pharmacist if you suffer from other illnesses, have allergies or are taking other medicines (even those you bought yourself!) or use externally or have recently taken or used externally!

ellaOne contains lactose

ellaOne contains lactose monohydrate. Therefore, please only take this medicine after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Trafficability and ability to use machines

This medicine can impair your ability to react, the ability to drive and the ability to use tools or machines! Some women experience dizziness, lightheadedness, blurred vision or impaired attention after taking ellaOne (see «What side effects can ellaOne have?»). If you notice these symptoms, you must not drive or use machines.

Can ellaOne be taken while pregnant or breastfeeding?

You must not take ellaOne if if you are pregnant. Before taking ellaOne, talk to your doctor or pharmacist if your period is late, or take a pregnancy test to make sure you are not already pregnant. ellaOne is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, taking it will not terminate the existing pregnancy.If you become pregnant despite taking ellaOne, it is essential that you contact your doctor. As with any pregnancy, the doctor will examine whether it is an ectopic or ectopic pregnancy. This is particularly important if you experience severe abdominal pain or bleeding, or if you have previously had an extrauterine pregnancy, an operation on the fallopian tubes, or a long-standing (chronic) infection of the genitals.

If You are breastfeeding

If you are taking ellaOne while breastfeeding, do not breastfeed your child for a week after taking ellaOne. During this period, you are advised to express and discard breast milk to stimulate and maintain milk production.

How do you use ellaOne?

Always take ellaOne exactly as your breastfeeder has told you doctor or pharmacist or your doctor or pharmacist. Please check with your doctor or pharmacist if you are not sure.

• Take as soon as possible and no more than 120 hours (5 days) after unprotected sex or contraceptive failure. Do not delay taking the tablets.You can take ellaOne at any time of the day and before, with or after a meal.You can take ellaOne at any time during your menstrual cycle.
• If you vomit within 3 hours of taking the ellaOne tablet, take a second tablet as soon as possible.If you have unprotected sex again after taking ellaOne, you will does not prevent pregnancy. For this reason, after taking ellaOne, you should use a condom every time you have sex until your next period.If you are using or have taken certain medicines in the past 4 weeks (see the section ?Taking ellaOne with other medicines"), ellaOne may be less effective for you. Talk to your doctor or pharmacist before taking ellaOne. Your doctor may prescribe another (non-hormonal) type of emergency contraception, i.e. a copper IUD. After taking ellaOne, it is normal for your next period to be delayed by a few days. However, if your period is delayed by more than 7 days, if it is unusually light or unusually heavy, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting or nausea, there is a chance that you are pregnant. In this case, do one immediatelyn Pregnancy test. If you are pregnant, you should definitely consult your doctor (see «Can ellaOne be taken during pregnancy or breastfeeding?»).

On the use of ellaOne in adolescents (including those Do not change the prescribed dosage on your own. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.

If you have taken more ellaOne than you should

So far, no serious harmful effects have been reported after taking multiple tablets at once. Nevertheless, you should contact your doctor or pharmacist in this case.If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

What side effects can ellaOne have?

The frequency of the side effects listed below is defined according to the following criteria:

• commonuncommonrarely

Common side effects:

• nausea, Abdominal pain, vomitingHeadache, dizzinessMenstrual pain, abdominal pain, breast tenderness, bleeding between periodsFatigueMood swings (e.g. depression) Muscle pain, back pain

Occasional side effects:

• Diarrhea, dry mouth, flatulence, indigestionabnormal or irregular vaginal bleeding or menstrual problems (heavy/prolonged periods, premenstrual syndrome)vaginal inflammation or dischargehot flushesfever, chillsPain, malaiseAnorexia, mood swings, anxiety, general physical agitation, insomnia, drowsiness, irritability, decreased/increased libidoAcne, rash, itching li>MigraineVisual disturbances

Rare side effects:

• Itching in the genital area, pain during sex, rupture of an existing ovarian cyst, genital pain, abnormally light periods, acid refluxDifficulty paying attention, dizziness, tremors, confusion, impaired sense of smell and taste, fainting Red eye, eye sensitivity to light,Increased thirst, chest discomfortDry throat, dehydrationHives

If you notice any side effects that are not described here, you should inform your doctor or pharmacist.

What else needs to be considered?

The medicine may only be used up to the date marked «EXP» on the container.

Keep the blister at room temperature (15-25°C) in the outer carton.

Medicines out of reach of Keep away from children.Your doctor or pharmacist can provide you with further information. These people have the detailed technical information.

What does ellaOne contain?

The active ingredient is ulipristal acetate. 1 film-coated tablet entholds 30 mg of ulipristal acetate. The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), polysorbate 80, iron oxide red oxide x H2O (E172), muscovite (E555).

Authorization number

66920 (Swissmedic).

Where can you get ellaOne? Which packs are available?

In pharmacies without a doctor's prescription.

In packs of 1 film-coated tablet.

Authorization holder

HRA-Pharma Switzerland Sàrl, 1260 Nyon.This leaflet was last checked by the drug authority (Swissmedic) in October 2018.